One challenge of cancer treatment is targeting specific treatment regimens to pathogenically distinct tumor types, and ultimately personalizing tumor treatment to maximize outcome. For example, prognostication of breast cancer can be difficult as such patients may remain free of distant metastasis even without adjuvant chemotherapy. While standard clinical traits (or biomarkers) struggle to identify “good prognosis” patients with adequate precision, analyses of gene expression patterns through molecular biology in primary tumors have resulted in more successful diagnostic tests. These tests use continuous measurements of mRNA concentrations of numerous genes to determine a risk of metastasis in lymph node negative (LN) breast cancer patients with other clinical traits. The decision to use adjuvant chemotherapy to treat early-stage breast cancer must balance a reduced risk of recurrence with the adjuvant chemotherapy's toxic effects.
Such tests include the 21-gene screening panel, Oncotype DX® (Genomic Health—Redwood City, Calif.; see also, Paik (2004) N. Engl. J. Med. 351:2817-2826 and Paik (2006) J. Clin. Oncol. 24:3726-3734), the 70-gene array-based test Mammaprint® (Agendia—Amsterdam; see also, de Vijver (2002) N. Engl. J. Med. 347:1999-2009 and Buyse (2006) J. Natl. Cancer Inst. 98:1183-1192) and Prosigna. These tests apply to lymph node-negative tumors with various other clinical traits, and utilize continuous measurements of mRNA concentrations of numerous genes.
An accelerated progression (AP) relapse test was described for assessing the relative prognostic value of a cancer treatment for a patient having been diagnosed with breast cancer (U.S. Pat. No. 8,597,885; and Buechler (2009) BMC Cancer 9:243).
A need continues to exist for alternative prognostication tests that provide predictive information about a recovering breast cancer patient's anticipated and/or likely probability for long-term survival. While the Oncotype DX, Mammaprint® and Prosigna assays provide assessment of the likelihood of recurrence of early-stage, estrogen receptor-positive (ER+) breast cancer, among other things, they do not outperform traditional parameters (such as tumor size, grade and patient age). Hence, additional screening and/or selection techniques are needed in the medical arts to advance and improve individual informed treatment decisions that can made for the breast cancer patient.